(137 days)
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied). There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 1 minute the device will shut down automatically. The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
The provided text describes the clinical validation study for the Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (from ISO 81060-2:2018) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Within ±5 mmHg (as per ISO 81060-2:2018) | Meets ±5 mmHg requirement |
| Pulse Rate Accuracy | Not explicitly stated in the document | Not explicitly stated in the document |
Note: The document explicitly mentions "The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg." This refers to blood pressure accuracy. While the Table 2 Performance Comparison lists "Pulse Accuracy: ±5% of reading value" as a specification for both the subject and predicate devices, it does not explicitly state that this was an acceptance criterion for the clinical validation or that the clinical study results confirmed this specific numerical accuracy for pulse rate. However, compliance with ISO 81060-2:2018 generally covers both BP and pulse rate accuracy indirectly through its clinical validation methodology for automated sphygmomanometers.
2. Sample Size and Data Provenance
- Sample Size (Test Set): 138 subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a prospective clinical trial, as "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement."
3. Number of Experts and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions:
- "Auscultation applied as gold standard"
- "qualified calibrated mercurial sphygmomanometer used as control group"
This implies that trained clinical personnel (likely physicians or nurses experienced in blood pressure measurement via auscultation) were involved in generating the ground truth.
4. Adjudication Method
The document does not specify an adjudication method like 2+1 or 3+1. The use of "Auscultation applied as gold standard" with a "qualified calibrated mercurial sphygmomanometer" suggests that the auscultation readings themselves were considered the definitive ground truth, potentially implying readings taken by at least two observers per subject to ensure accuracy, though this is not explicitly detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.
6. Standalone Performance
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The clinical trial directly evaluated the device's accuracy in measuring blood pressure against the auscultation gold standard.
7. Type of Ground Truth Used
- Expert Consensus / Reference Method: The ground truth was established by auscultation using a "qualified calibrated mercurial sphygmomanometer." This is considered a clinical reference method, often performed by trained experts.
8. Sample Size for the Training Set
- The document does not mention a separate training set or its sample size. The description of the clinical trial refers to the validation of the device's performance after its development.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as a separate training set and its ground truth establishment method are not described in the provided text. The clinical trial described is for validation of the device's performance.
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May 31, 2022
Shenzhen Finicare Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 CHINA
Re: K220113
Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 21, 2022 Received: April 27, 2022
Dear Boyle Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Upper Arm Electronic Blood Pressure Monitor(Model:FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
Indications for Use (Describe)
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K220113
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Address: | 201, No.50, the 3rd Industrial Park, Houting CommunityShajing Street, Bao'an District, Shenzhen 518104 China |
| Tel: | 86-755-23013503 |
| Contact: | Chao Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 608, No. 738 Shangcheng Rd., Pudong Shanghai,200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: May.29,2022
2.0 Device Information
| Trade name: | Upper Arm Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive Blood Pressure Measurement System |
| Classification name: | Noninvasive Blood Pressure Measurement System |
| Model(s): | FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111FC-BP112 |
| Production code: | DXN |
| Regulation number: | 21 CFR 870.1130 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
Manufacturer: Truly Instrument Limited Trade name: Arm Blood Pressure Monitor,Model: DB66-1, DB68
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510(k) number: K192023
4.0 Indication for Use Statement
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
5.0 Device Description
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables
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the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied).
There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 1 minute the device will shut down automatically.
The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
6.0 _Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
EN 300328:2019 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques.
301489-1:2019 ElectroMagnetic Compatibility (EMC)standard for radio EN equipment and services;Part 1:Common technical requirements.
EN 301489-17:2020 Electromagnetic compatibility and Radio spectrum Matters
(ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems.
EN 62479:2010 Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHZ to 300 GHZ )
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
7.0 Clinical Test Conclusion
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Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Upper Arm Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 138 subjects been selected to participate in the trial, and Auscultation applied as gold standard with the qualified calibrated mercurial was was was and sphygmomanometer used as control group for comparison with the subject device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
8.0 Technological Characteristic Comparison Table
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| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject DeviceK220113 | Predicated DeviceK192023 | Remark |
| Manufacturer | Shenzhen Finicare Co., Ltd. | Truly Instrument Limited | / |
| Product Name | Upper Arm Electronic BloodPressure Monitor:FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112 | Arm Blood Pressure MonitorDB66-1, DB68 | / |
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE |
| Class | II | II | SE |
| IntendedUse/Indicationfor Use | Upper Arm Electronic BloodPressure Monitor, Models FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112 areintended to measure the systolicand diastolic blood pressure andpulse rate of an adult individual byusing a non-invasive technique inwhich an inflatable cuff iswrapped around the upper arm.The devices' features includeirregular pulse rhythm detectionduring measurement, and willdisplay a alert signal with thereading when irregular heartbeatis detected.The devices' feature includesBluetooth function to transmitdata to an external Bluetoothdevice with wirelesscommunication. | Automatic Arm Blood PressureMonitor DB series, ModelsDB66-1, DB68 are a seriesdevices intended to measurethe systolic and diastolic bloodpressure and pulse rate of anadult individual by using a non-invasive technique in which aninflatable cuff is wrappedaround the upper arm.The devices' features includeirregular pulse rhythmdetection during measurement,and will display a alert signalwith the reading when irregularheartbeat is detected.The devices' feature includeBluetooth function to transmitdata to an external Bluetoothdevice with wirelesscommunication. | SE |
| Application Site | Upper Arm | Upper Arm | SE |
| CuffCircumference | 22-42cm | Not Publicly available | Different |
| PatientsContactingMaterials | Patient contact materials of thecuff: 210D Nylon TPUAccording to ISO-10993 | CuffAccording to ISO-10993 | SE |
| PatientPopulation | Adult | Adult | SE |
| MeasurementsItem | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Display | LCD Digital Display | Liquid crystal display | SE |
Table1-General Comparison
Table 2 Performance Comparison
| ltem | Subject Device | Predicate DeviceK192023 | Remark |
|---|---|---|---|
| Max Cuff | 300mmHg | 300mmHg | SE |
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| pressure | |||
|---|---|---|---|
| BP Range | 0-299 mmHg | 20 ~ 280 mmHg | Different |
| BP Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | SE |
| PR Range | 40-180 beats/min | 40 ~ 195 beats/min | Different |
| Pulse Accuracy | $\pm$ 5% of reading value | $\pm$ 5% of reading value | SE |
| Irregular heartbeat detection | More than $\pm$ 25% to the mean interval of pulse intervals. | More than $\pm$ 25% to the mean interval of pulse intervals. | SE |
| Inflation Method | Automatic inflation by pump | Automatic internal pump | SE |
| Deflation Method | Automatic rapid deflation | Automatic deflation | SE |
| Memory Size | 2x90 set of data | 99 set | Different |
| Operation Condition | 10 | 10 | Different |
| Storage Condition | -20 | -20℃~60℃,10%~95%RH | Different |
| Performance Standard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | SE |
| Power Supply | 4 AA batteries or DC6V, or USB Type C (DC5V1A) | Polymer battery DC3.7V, 500mAh.Or 4x 1.5V AA Battery | Different |
Analysis:
The subject and predicate device have same general intended use, similar design features and performance specifications.
The differences in BP Range, PR Range and Memory Size do not raise different questions of safety or effectiveness since the device complied with the requirement of IEC 80601-2-30.
The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. So we think the subject device is substantially equivalent to the predicate device.
| Item | Proposed Device | Predicate DeviceK192023 | Remark | |||
|---|---|---|---|---|---|---|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE | |||
| Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | SE | |||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | |||
| FCC conformity | FCC 47 part 15 subject B | FCC 47 part 15 subject B | SE | |||
| ERM conformity | EN 301489-1:2017:EN301489-17:2017 | EN301489-1:2017:EN301489-17:2017 | SE | |||
| RF conformity | EN300328:2016 | EN300328:2016 | SE |
Table 3 Safety Comparison
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| Health | EN62479:2010 | EN62479:2010 | SE |
|---|---|---|---|
| Biocompatibility | Comply with ISO 10993-1,FDA Guidance | Comply with ISO 10993-1, FDAGuidance | SE |
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).